Dr. Flinn on FDA Approval of Tisagenlecleucel in DLBCL

Ian W. Flinn, MD, PhD
Published: Tuesday, May 01, 2018



Ian W. Flinn, MD, PhD, director of Lymphoma Research, principal investigator, Sarah Cannon Research Institute, discusses the FDA approval of the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) for use in adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL).

The approval is based on the phase II JULIET study, in which the CD19-directed CAR T-cell therapy reached an overall response rate of 50% (95% CI, 38%-62%) in adult patients with relapsed/refractory DLBCL. The complete response rate was 32% and the partial response rate was 18%. The median duration of response had not been reached.

This approval also includes patients with high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma after 2 or more lines of systemic therapy. At the data cutoff, 147 patients were enrolled, 99 of whom were infused with a single dose of tisagenlecleucel transduced cells (median, 3.1 x 108cells; range, 0.1-6.0 x 108). 
 


Ian W. Flinn, MD, PhD, director of Lymphoma Research, principal investigator, Sarah Cannon Research Institute, discusses the FDA approval of the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) for use in adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL).

The approval is based on the phase II JULIET study, in which the CD19-directed CAR T-cell therapy reached an overall response rate of 50% (95% CI, 38%-62%) in adult patients with relapsed/refractory DLBCL. The complete response rate was 32% and the partial response rate was 18%. The median duration of response had not been reached.

This approval also includes patients with high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma after 2 or more lines of systemic therapy. At the data cutoff, 147 patients were enrolled, 99 of whom were infused with a single dose of tisagenlecleucel transduced cells (median, 3.1 x 108cells; range, 0.1-6.0 x 108). 
 



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